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EN
SA-15-07-25-962
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Corin Operating Tables
الأجهزة المتأثرة
Item number (Serial number): 770001A0 (1-28 (27 devices)), 770001A2 (5-59 (46 devices)), 770001B0 (5-97 (87 devices)), 770001B2 (3-194 (146 devices)), 770001F0 (1-7 (7 devices)), 770001F2 (4-15 (5 devices)). please refer to the attachmnet for more details.
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
Under certain conditions – such as the simultaneous use of the operating table with other medical devices that may cause interference, including high-frequency (HF) surgical equipment – Getinge has identified a potential issue that could prevent the device from performing as intended. If the issue occurs, the Corin operating table (7700.01XY) does not respond to any command.
الإجراء التصحيحي
The device can be used in accordance with the instructions for use. If the issue occurs, the user should, if possible, deactivate or disable any devices that may interfere with the proper functioning of the Corin operating table, please refer to the attchment for more information. A software update that will mitigate the described issue has been developed by Getinge. Getinge will correct all affected device units. In the case, after the software update, the Corin operating table can no longer be operated by the control device or the override control panel, you may proceed as described in the attachment. Manufacturer action: Instructions and correction.
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